Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Lymphoma, B-Cell

Lymphoma, Non-Hodgkin

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

B-cell Lymphoma

All Drugs and Chemicals

Antibodies

Antibodies, Monoclonal

Immunoglobulins

B-cell NHL patients treated with novel MAB in Italian real life (approved by EMA since 2020 and prescribed according to the indications for use authorized for marketing in Italy).

Patients first-line and relapsed or refractory who had received at least 1 dose of MAB.

Different cohorts will be analyzed according to approved treatment indications, type of antibody employed and NHL hystotypes.

"novel" MAB (alone or in combination) based on presence of an EMA clinical indication since 2020 and prescribed according to the indications for use authorized for marketing in Italy

"novel" MAB (alone or in combination)

Uffici Studi FIL

Giulio Antonio Milone, MD

Roberta Giachetti, MD

Marco Ladetto, Prof.

Guido Gini, MD

Sonya De Lorenzo, MD

Michele Spina, MD

Giacomo Loseto, MD

Giuseppe Tarantini, MD

Alessandro Rambaldi, MD

Beatrice Casadei, MD

Alessandro Re, MD

Maria Pina Simula, MD

Pio Manlio Mirko Frascione, MD

Roberta Della Seta, MD

Mariella Lo Schirico, MD

Ugo Consoli, MD

Annalisa Chiarenza, MD

Caterina Bocci, MD

Alessia Castellino, MD

Luca Nassi, MD

Federico Simonetti, MD

Sofya Kovalchuk, MD

Alessandro Allegra, MD

Vittorio Ruggero Zilioli, MD

Paolo Corradini, Prof.

Andrès Ferreri, MD

Federica Cocito, MD

Fabrizio Pane, Prof.

Riccardo Bruna, MD

Dario Marino, MD

Catello Califano, MD

Caterina Patti, MD

Luca Arcaini, Prof.

Elsa Pennese, MD

Annalisa Arcari, MD

Michele Cimminiello, MD

Monica Tani, MD

Caterina Stelitano, MD

Stefano Luminari, Prof.

Giuseppe Pietrantuono, MD

Agostino Tafuri, Prof.

Alice Di Rocco, MD

Luigi Rigacci, MD

Monica Balzarotti, MD

Claudio Fozza, Prof.

Sara Bigliardi, MD

Alberto Fabbri, MD

Angelo Fama, MD

Anna Marina Liberati, Prof.

Federica Cavallo, MD

Maura Nicolosi, MD

Elisabetta Scarpa, MD

Vincenzo Pavone, MD

Francesco Zaja, Prof.

Jacopo Olivieri, MD

Carlo Visco, Prof.

Maria Chiara Tisi, MD

This is a prospective, observational cohort study to evaluate the clinical impact of novel Monoclonal AntiBodies (MAB) in B-cell Non-Hodgkin Lymphoma (NHL) in Italian clinical practice.

This is a large prospective, observational cohort study aimed at collecting clinical information on use, feasibility, short- and long-term efficacy and short- and long-term toxicity of novel MAB that have received approval from EMA since 2020 and are prescribed according to the indications for use authorized for marketing in Italy.

Patients entering the study will be subdivided into different cohorts based on approved treatment indications, type of antibody employed and histological subtype. Additional sub-cohorts will be defined if needed.

Final outputs will be based according to:

* Per indication analysis;
* Pooled analyses by type of antibody and subtype and other parameters;
* A general analysis of the whole cohort.

A Prospective, Observational Cohort Study on the Clinical Impact of Novel Monoclonal Antibodies in B-cell Non-Hodgkin Lymphoma in Italian Clinical Practice

A Prospective, Observational Cohort Study to Evaluate the Clinical Impact of Novel Monoclonal Antibodies (MAB) in B-cell Non-Hodgkin Lymphoma (NHL) in Italian Clinical Practice

ORR will be defined according to Lugano 2014 criteria as the proportion of patients who have a partial response (PR) or complete response to therapy (CR+PR).

CRR will be defined according to Lugano 2014 criteria and will include only patients who achieved a CR at the end of treatment program. The best overall response will be defined as the best response between the date of beginning of therapy and the last restaging. Patients without response assessment (due to whatever reason) will be considered as non-responders.

PFS is defined as the time between the date of enrollment and the first documentation of recurrence, progression or death from any cause; responding patients and patients who are lost to follow up will be censored at their last assessment date.

OS is defined as the time between the start of treatment until death from any cause; patients who are lost at follow up will be censored at their last assessment date.

ESFS is defined as the time from start of treatment to disease progression, death, or discontinuation of treatment for any reason (e.g. toxicity, patient preference), or initiation of a new treatment without documented progression.

TTNT represents the interval from commencement of one treatment to initiation of the next line of therapy.

NRM is defined as death without recurrent or progressive disease after treatment.

DOR is defined as the time from the first documentation of tumor response (CR/PR) to disease progression or death according to Lugano 2014 criteria.

Toxicities will be recorded and classified according to the definitions of the latest version of the NCI CTCAE. Toxicity events will be determined by the incidence of severe, life-threatening (CTCAE grade 3, 4 and 5) and/or serious adverse events (SAEs) commencing after the first induction dose or at any time during therapy. Early and toxic deaths and cause of any death. Special focus on second tumors, infections and autoimmune complications. Particularly:

* Hematological and extra-hematological toxicities Grade \> 2
* Infusional adverse events, will be recorded any Grade
* Toxicities of specific interest on second tumors, infections and autoimmune complications will be recorded any Grade
* Early and toxic deaths and cause of any death.

Roche Pharma AG

Fondazione Italiana Linfomi - ETS

Spots Global Cancer Trial Database for novel antibodies